Shilpa Biologicals Signs Europe Deal with Orion for Cancer Drug Nivolumab Biosimilar
New Delhi: Shilpa Biologicals Private Limited (SBPL), a wholly owned subsidiary of Shilpa Medicare Limited, has entered into a co-development and supply agreement with Orion Corporation, Finland, for the development, manufacture and supply of an intravenous (IV) nivolumab biosimilar for the European market.
The company disclosed the development under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, stating that the agreement has been executed with Orion Corporation, a globally recognised pharmaceutical company headquartered in Finland.
According to the filing, the collaboration covers the co-development and supply of an IV nivolumab biosimilar, one of the world's most widely used cancer immunotherapies. The agreement has been signed with an international entity and does not involve any joint venture ratio or share exchange ratio. The financial consideration has not been disclosed and has been classified as confidential.
Under the agreement, Shilpa Biologicals will co-develop, manufacture and exclusively supply the intravenous nivolumab biosimilar for the European market from its advanced biologics manufacturing facility in Dharwad, India. Orion Corporation will hold the exclusive rights to register, market, distribute and sell the biosimilar across Europe and will act as the Marketing Authorisation Holder for the territory. Shilpa will receive development and regulatory milestone payments from Orion, in addition to long-term supply revenue generated over the duration of the partnership.
The company clarified that Orion Corporation is not a related party to Shilpa Medicare, Shilpa Biologicals, the promoter, promoter group or group companies. The partnership aims to leverage the loss of exclusivity of the originator nivolumab to improve patient access to a high-quality, EU-GMP-manufactured biosimilar across Europe.
Nivolumab is among the world's most widely used PD-1 immuno-oncology therapies and helped usher in the era of cancer immunotherapy by improving outcomes in cancers including melanoma and lung cancer. According to IQVIA/IMS, nivolumab generated approximately USD 4.1 billion in sales in Europe during 2025, highlighting the significant opportunity for biosimilars to improve patient access while helping healthcare systems manage oncology treatment costs.
The companies stated that the collaboration is expected to expand access to advanced immuno-oncology therapy, improve affordability of cancer treatment and reduce pressure on healthcare budgets across Europe. It also builds on the companies' earlier partnership to commercialise Shilpa's Recombinant Human Albumin in Europe, further strengthening their strategic collaboration.
Commenting on the partnership, Vishnukant Bhutada, Managing Director, Shilpa Medicare, said extending the collaboration with Orion into immuno-oncology marks a defining moment for Shilpa Biologicals and reflects the confidence placed in the company's scientific capabilities, manufacturing quality and ability to deliver complex biologics at commercial scale. He added that the agreement advances Shilpa's mission of making advanced medicines more affordable and accessible worldwide.
Satu Ahomäki, Executive Vice President, Generics and Consumer Health, Orion Pharma, said the agreement adds another product to the strategic partnership with Shilpa and supports Orion's efforts to expand and strengthen its hospital business across Continental Europe while advancing its strategy of improving access to affordable, high-quality medicines.
According to the Shilpa Medicare press release, Shilpa Medicare is a diversified pharmaceutical and biotechnology company engaged in the development and manufacture of complex generics, biologics and active pharmaceutical ingredients (APIs). Through Shilpa Biologicals, the company operates a fully integrated biologics platform covering development, scale-up and commercial manufacturing at its EU-GMP-certified biologics facility in Dharwad, India. Orion Corporation is a globally operating Nordic pharmaceutical company engaged in the development, manufacture and marketing of human and veterinary pharmaceuticals, active pharmaceutical ingredients and consumer healthcare products, with research focused on oncology and pain. The company also develops therapies for respiratory and neurological diseases. In 2025, Orion reported net sales of EUR 1.89 billion and employed around 4,000 professionals worldwide.
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